PharmaceuticalOutsourcingQ42020 - 56

HORIZON LINES: A QUARTERLY REVIEW OF NDAs

Approval
Date

Drug Name

Active Ingredients

Submission
Classification

Type of Dosage
Form/ Route

Company

Comments

08/05/2020

Blenrep

Belantamab
Mafodotin-Blmf

BLA

Injectable,
Intravenous

GlaxoSmithKline

Monotherapy treatment for adult patients with relapsed or
refractory multiple myeloma

08/06/2020

Lampit

Nifurtimox

Type 1 - New
Molecular Entity

Tablet; Oral

Bayer Healthcare

Is a nitrofuran antiprotozoal used for the treatment of Chagas
disease (American Trypanosomiasis) in pediatric patients.

08/07/2020

Olinvyk

Oliceridine

Type 1 - New
Molecular Entity

Injectable;
Intravenous

Trevena Inc.

An opioid agonist for the management of moderate to severe
acute pain in adults.

08/07/2020

Evrysdi

Risdiplam

Type 1 - New
Molecular Entity

For Solution; Oral

Genentech Inc.

For Treatment of Spinal Muscular Atrophy (SMA) in Adults and
Children 2 Months and Older

08/12/2020

Viltepso

Viltolarsen

Type 1 - New
Molecular Entity

Solution;
Intravenous

Nippon Shinyaku

First and only exon 53 skipping treatment to demonstrate an
increase in dystrophin in children as young as four years old.

08/14/2020

Enspryng

Satralizumab

BLA

Injectable;
Injection

Genentech

First and only subcutaneous treatment for Neuromyelitis Optica
Spectrum Disorder

08/19/2020

Cystadrops

Cysteamine
Hydrochloride

Type 5 - New
Formulation or
New Manufacturer

Solution/Drops;
Ophthalmic

Recordati Rare

First and only FDA-approved cysteamine drop formulation with
four times a day dosing for the Ocular Manifestations of Cystinosis

08/21/2020

Pemetrexed

Pemetrexed

Type 2 - New
Active Ingredient

Solution;
Intravenous

Actavis LLC

Approved under 505(b)(2) submission.

08/24/2020

Methotrexate

Methotrexate

_

Solution;
Intravenous

Accord Healthcare

Approved under 505(b)(2) submission.

08/26/2020

Winlevi

Clascoterone

Type 1 - New
Molecular Entity

Cream; Topical

Cassiopea Spa

Non-antibiotic cream for the Treatment of Acne

08/28/2020

Xaracoll

Bupivacaine
Hydrochloride

Type 3 - New
Dosage Form
and Type 4 - New
Combination

Implant;
Implantation

Innocoll
Pharmaceutical

First and only drug-device combination product for
Acute Postsurgical Pain Relief Following Open Inguinal
Hernia Repair

08/28/2020

Sogroya

Somapacitan-Beco

BLA

Solution;
Subcutaneous

Novo Nordisk Inc.

Once-Weekly Treatment for Adult Growth Hormone Deficiency

09/01/2020

Qdolo

Tramadol
Hydrochloride

Type 3 - New
Dosage Form

Solution; Oral

Athena

Management of pain severe enough to require an opioid analgesic.

09/01/2020

Onureg

Azacitidine

Type 3 - New
Dosage Form

Tablet; Oral

Celgene Corp.

Azacitidine tablets as Continued Treatment for Adults in First Remission with Acute Myeloid Leukemia

09/03/2020

Detectnet

Copper Dotatate
Cu-64

Type 1 - New
Molecular Entity

Solution;
Intravenous

Radiomedix

Positron emission tomography (PET) agent for diagnosis of
neuroendocrine tumors

09/04/2020

Gavreto

Pralsetinib

Type 1 - New
Molecular Entity

Capsule; Oral

Blueprint
Medicines

Once-daily, oral precision therapy for the Treatment of
Adults with Metastatic RET Fusion-Positive Non-Small
Cell Lung Cancer

09/25/2020

Xeljanz

Tofacitinib Citrate

Type 3 - New
Dosage Form

Solution; Oral

Pfizer Inc.

New dosage form as oral solution

09/29/2020 Alkindi Sprinkle

Hydrocortisone

Type 3 - New
Dosage Form

Capsule; Oral

Diurnal Ltd

First and only FDA-approved granular hydrocortisone formulation
for the treatment of Pediatric Adrenocortical Insufficiency

09/29/2020 Atropine Sulfate

Atropine Sulfate

Type 5 - New
Formulation or Solution; Injection Accord Healthcare
New Manufacturer

Pharmaceutical Outsourcing |

56

| October/November/December 2020

Temporary blockade of severe or life-threatening
muscarinic effects.



PharmaceuticalOutsourcingQ42020

Table of Contents for the Digital Edition of PharmaceuticalOutsourcingQ42020

Editor's Message
Editorial Advisory Board
CN Perspectives
Social Media Connections
Insider Insight - Price
Insider Insight - Ventura
Contract Manufacturing
Supply Chain
Contract Manufacturing
Interview with Yourway
Supply Chain
Clinical Trials
Roundtable
Supply Chain
Analytical Testing
Supply Chain
Clinical Trials
Analytical Testing
Horizon Lines
Industry News
Advertiser's Index
PharmaceuticalOutsourcingQ42020 - Cover1
PharmaceuticalOutsourcingQ42020 - Cover2
PharmaceuticalOutsourcingQ42020 - 1
PharmaceuticalOutsourcingQ42020 - Editor's Message
PharmaceuticalOutsourcingQ42020 - 3
PharmaceuticalOutsourcingQ42020 - 4
PharmaceuticalOutsourcingQ42020 - 5
PharmaceuticalOutsourcingQ42020 - Editorial Advisory Board
PharmaceuticalOutsourcingQ42020 - 7
PharmaceuticalOutsourcingQ42020 - CN Perspectives
PharmaceuticalOutsourcingQ42020 - Social Media Connections
PharmaceuticalOutsourcingQ42020 - Insider Insight - Price
PharmaceuticalOutsourcingQ42020 - 11
PharmaceuticalOutsourcingQ42020 - Insider Insight - Ventura
PharmaceuticalOutsourcingQ42020 - 13
PharmaceuticalOutsourcingQ42020 - Contract Manufacturing
PharmaceuticalOutsourcingQ42020 - 15
PharmaceuticalOutsourcingQ42020 - 16
PharmaceuticalOutsourcingQ42020 - 17
PharmaceuticalOutsourcingQ42020 - Supply Chain
PharmaceuticalOutsourcingQ42020 - 19
PharmaceuticalOutsourcingQ42020 - Contract Manufacturing
PharmaceuticalOutsourcingQ42020 - 21
PharmaceuticalOutsourcingQ42020 - Interview with Yourway
PharmaceuticalOutsourcingQ42020 - 23
PharmaceuticalOutsourcingQ42020 - Supply Chain
PharmaceuticalOutsourcingQ42020 - 25
PharmaceuticalOutsourcingQ42020 - 26
PharmaceuticalOutsourcingQ42020 - 27
PharmaceuticalOutsourcingQ42020 - 28
PharmaceuticalOutsourcingQ42020 - 29
PharmaceuticalOutsourcingQ42020 - Clinical Trials
PharmaceuticalOutsourcingQ42020 - 31
PharmaceuticalOutsourcingQ42020 - 32
PharmaceuticalOutsourcingQ42020 - Roundtable
PharmaceuticalOutsourcingQ42020 - 34
PharmaceuticalOutsourcingQ42020 - 35
PharmaceuticalOutsourcingQ42020 - Supply Chain
PharmaceuticalOutsourcingQ42020 - 37
PharmaceuticalOutsourcingQ42020 - 38
PharmaceuticalOutsourcingQ42020 - 39
PharmaceuticalOutsourcingQ42020 - Analytical Testing
PharmaceuticalOutsourcingQ42020 - 41
PharmaceuticalOutsourcingQ42020 - 42
PharmaceuticalOutsourcingQ42020 - 43
PharmaceuticalOutsourcingQ42020 - Supply Chain
PharmaceuticalOutsourcingQ42020 - 45
PharmaceuticalOutsourcingQ42020 - 46
PharmaceuticalOutsourcingQ42020 - 47
PharmaceuticalOutsourcingQ42020 - Clinical Trials
PharmaceuticalOutsourcingQ42020 - 49
PharmaceuticalOutsourcingQ42020 - 50
PharmaceuticalOutsourcingQ42020 - Analytical Testing
PharmaceuticalOutsourcingQ42020 - 52
PharmaceuticalOutsourcingQ42020 - 53
PharmaceuticalOutsourcingQ42020 - Horizon Lines
PharmaceuticalOutsourcingQ42020 - 55
PharmaceuticalOutsourcingQ42020 - 56
PharmaceuticalOutsourcingQ42020 - 57
PharmaceuticalOutsourcingQ42020 - Industry News
PharmaceuticalOutsourcingQ42020 - 59
PharmaceuticalOutsourcingQ42020 - 60
PharmaceuticalOutsourcingQ42020 - 61
PharmaceuticalOutsourcingQ42020 - 62
PharmaceuticalOutsourcingQ42020 - 63
PharmaceuticalOutsourcingQ42020 - Advertiser's Index
PharmaceuticalOutsourcingQ42020 - Cover3
PharmaceuticalOutsourcingQ42020 - Cover4
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